Internet drug sales must be regulated, say EU legislators

European parliamentarians voted overwhelmingly yesterday to include Internet drug sales in European Union (EU) legislation aimed at preventing counterfeit medicines from entering the supply chain.

Internet sales were not included in the original draft legislation put forward by the European Commission in December 2008. Their inclusion, proposed by Marisa Matias, a member of the Portuguese European United Left–Nordic Green Left (EUL-NGL), was supported in a 51-0 vote (with three abstentions) by the European Parliament's environment, public health and food safety (ENVI) committee.

“There has been a dangerous increase in falsified medicines on the market in recent years, with some products infiltrating legal supply chains and posing a serious threat to patients. On several counts, the original Commission proposal was not up to the mark,” said Ms Matias.

Under the proposals backed by the ENVI panel yesterday, Internet pharmacies would have to obtain special authorizations in EU member states where they are allowed to operate. Their sites would be required to bear an EU logo to indicate that they are linked to an authorised pharmacy, and they would be listed in a European database. Information for the public about the risks involved in buying medicines on the Internet would have to be provided.

Mandatory safety features such as seals or serial numbers would be required for prescription medicines, although this obligation could be waived, for example in the case of generics, subject to an assessment by the European Commission. Moreover, after four years the Commission would be required to assess whether this requirement should be extended to non-prescription medicines, the MEPs agreed.

They have also called for stronger sanctions against drug counterfeiters, supporting proposals from the Council of Europe to make the trade a criminal offence. They voted to allow repackaging of medicines by parallel traders to continue - the original Commission package had sought to ban the practice.

Ms Mathias’ report included 15 amendments to the Commission’s original Falsified Medicines Directive, and without them, she said: “the Internet would have operated as the Trojan horse for fake medicines. We cannot leave the largest gateway for counterfeit drugs in Europe out of this legislation."

However, many of the MEPs still feel the proposals do not go far enough. Frustrated at the decision to allow repackaging to continue, Francoise Grossetete, a French member of the centre-right European People’s Party (EPP), said: “you are not allowed to repackage a box of spaghetti...I don't know why we are tolerating this.”

In February, research commissioned by Pfizer estimated that one in five Europeans have purchased prescription-only medicines from illicit sources, and that the counterfeit medicines market in Europe is worth more than 10.5 billion euros per year.

And a new study published today put the figures even higher, estimating that 9% of European consumers have purchased prescription drugs on-line at least once, even though 69% of those surveyed agreed that it is “a bad idea or dangerous” to do so.

46% of those who had done so said it was because buying on-line was cheaper while 30% did so because of convenience, according to the study, which was conducted for patient safety company Aegate.

“Despite the fact that purchasing prescription medicines on-line is illegal in most European countries, Internet pharmacy web sites can be registered anywhere in the world and accessed from most computers, making it almost impossible to stem the availability of prescription drugs on-line,” said Aegate chief executive Gary Noon.

The survey also found that, in countries where buying medicines on-line is legal, 26% of consumers do so – 18% regularly – with 57% saying they did so because it was cheaper, and 37% expressing concern about the risks of obtaining their medicines in this way.

- The European Parliament is due to vote on the Falsified Medicines Directive in July. Also yesterday, the ENVI Committee approved the proposals within the Commission’s pharmaceutical package aimed at improving companies’ pharmacovigilance systems and reporting of adverse reactions. It is scheduled to debate the patient information section of the package in June.